Events

Recall of Getinge 46-Series Washer Disinfector with PACS 300/350

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Getinge Australia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2015-RN-00174-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2015-03-12
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00174-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Extra notes in the data
  • Reason
    The manufacturer has received complaints in germany regarding sediment residuals in the manifold of the washer and disinfector of getinge 46-series (cm302) with pacs 300/350 control.The potential risk is that during the drying phase the air circulating may transport particles from the sedimentation and deposit it on goods. if the particle contains bacterial flora there is the risk of cross contamination.The problem has been identified as insufficient water flow throughout the manifold due to formation of air-pockets where sedimentation may occur. the use of detergents that are not recommended might also have negative impact.No serious injury has been reported in any of the known cases.
  • Action
    Getinge will contact customers to carry out a modification that will permanently mitigate the risk of this issue occurring in the future. In the interim customers are advised to perform a visual check of all washed items after removal from the washer. Items should be re-washed if any particles are observed. This action has been closed-out on 1/06/2016.

Device

Getinge 46-Series Washer Disinfector with PACS 300/350

Manufacturer

Getinge Australia Pty Ltd
  • Manufacturer Parent Company (2017)
    Getinge AB
  • Source
    DHTGA